Strados Gains FDA Clearance for Remote Lung-Sound System
Pennsylvania-based Strados Labs has received the FDA’s 510(k) clearance for its Strados RESP, a platform used to record, measure and assess lung sounds remotely.
After applying a small, wearable sensor to patients, the system can remotely capture and analyze changes in a patient’s lung sounds. The system uses cloud-based software and it can be integrated into telehealth, electronic intensive care units, clinical trial management platforms and telemetry, the company said.
Strados Labs is collaborating with research organizations and drugmakers to capture lung-sound measurements as endpoints in their clinical trials.